A Registry for Patients Taking Uptravi

NCT03278002 | Completed

• 1 other identifier: AC-065A402
• Study Type: observational
• Target: 800
• Locations: 2 countries
• Sites: 85

Brief Summary

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• Using Electronic Medical Records, the change in Hemodynamics (by Right Heart Catherization), WHO FC and 6 Minute Walk Distance (by meters) from diagnosis to registry enrollment and to EOS will be measured/collected.

  To describe demographics and disease characteristics of patients treated with Uptravi.

  Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

• The initial dose (in micrograms), dose at selected intervals (in days), highest dose, maintenance dose, time between titrations, time from initiation to maintenance dose (in days) and total duration of exposure to Uptravi (in days) will be collected.

  To describe the dosing regimens and titration of Uptravi, including any transition from other PAH specific therapies to Uptravi and from Uptravi to other prostanoids.

  Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

• Occurrence of AEs and SAEs (incl. hospitalizations), discontinuation of Uptravi and reason for stopping and occurrence of all-cause death by relationship to PAH.

  To describe the clinical course of patients treated with Uptravi.

  Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Study Arms (1)

Group/Cohort Information

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The number of patients planned to be enrolled in the study is approximately 800 patients from approximately 80 centers in the U.S.

You may qualify if:

• Signed patient informed consent form (ICF).
• Patients ≥ 18 years of age at time of Uptravi initiation, and
• Patients who initiate Uptravi:
• at enrollment, or
• less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)

You may not qualify if:

• Patients previously exposed to Uptravi treatment during a clinical trial.
• Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
• Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.

Sponsors & Collaborators

• Actelion: lead

Study Sites (85)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

Cardioivascular Consultants, Ltd.

Phoenix, Arizona, 85027, United States

Location

University of Arizona-Clinical Translational and Regenerative Medicine

Tucson, Arizona, 85724, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

VA Greater Los Angeles Healthcare Center

Los Angeles, California, 90073, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA

Torrance, California, 90502, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Banner Health Research Institute

Greeley, Colorado, 80631, United States

Location

Florida Lung Asthma and Sleep Specialists

Celebration, Florida, 34747, United States

Location

Broward Pulmonary and Sleep

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida, HSC

Gainesville, Florida, 32610, United States

Location

West Pasco Pulmonary Associates

Hudson, Florida, 34667, United States

Location

University of Florida-Jacksonville College of Medicine

Jacksonville, Florida, 32209, United States

Location

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Wellstar Marietta Pulmonary Medicine

Marietta, Georgia, 30060, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, 46260, United States

Location

CIC Associates

Clive, Iowa, 50325, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Norton Pulmonary Specialists

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Oschner Clinic Foundation/Oschner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Chest Medicine Associates

South Portland, Maine, 04106, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts University Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Research, Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Somnos Clinical Research

Lincoln, Nebraska, 68510, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Pulmonary Health Physicians, PC

Fayetteville, New York, 13066, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weil Cornell Medicine

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina Hospitals at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Southwest General Health Center

Middleburg Heights, Ohio, 44130, United States

Location

Legacy Medical Group-Pulmonary and Sleep Clinic

Portland, Oregon, 97210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17402, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

AnMed Health Medical Center

Anderson, South Carolina, 29621, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Scott and White Health

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas, Houston Health Center

Houston, Texas, 77030, United States

Location

Methodist Healthcare of San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax

Falls Church, Virginia, 22042, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Multicare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53150, United States

Location

Aurora Research Institute / Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

CardioPulmonary Research, PSC

Guaynabo, 00917, Puerto Rico

Location

Related Publications (1)

• Kim NH, Hemnes AR, Chakinala MM, Highland KB, Chin KM, McLaughlin V, Zhao C, Narayan V, Farber HW. Patient and disease characteristics of the first 500 patients with pulmonary arterial hypertension treated with selexipag in real-world settings from SPHERE. J Heart Lung Transplant. 2021 Apr;40(4):279-288. doi: 10.1016/j.healun.2021.01.006. Epub 2021 Jan 15.

  PMID: 33526303 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Actelion

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 11, 2017
• Study Start: November 1, 2016
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

PR (1); US (84)